FDA Expands Use of DigniCap to Prevent Chemotherapy-induced Hair Loss

The DigniCap Cooling System, a scalp-cooling system designed by Dignitana to reduce hair loss due to chemotherapy, was approved by the U.S. Food and Drug Administration (FDA) to be used in patients with solid tumor cancers, including ovarian cancer.

“We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” Binita Ashar, MD, director of the Surgical Devices Division in the FDA’s Center for Devices and Radiological Health, said in a press release. “Managing the side effects of chemotherapy is a critical component to overall health and quality of life.”

A common side effect of chemotherapy treatments is hair loss. This effect may affect some regions of the scalp, making the hair thinner or causing complete hair loss.

Although it usually is temporary, the effects can influence the patient’s quality of life and overall self-esteem, and eventually their mental health. Finding ways to minimize these side effects are relevant for the overall success of the therapies.

DigniCap is a computer-operated system designed to induce blood vessel constriction in the scalp, reducing the amount of drug that reaches the hair follicles, and making them less affected by the chemotherapy. The device consists of a cap that is worn during the chemotherapy session, in which a cold liquid with controlled temperature circulates continuously.

In 2015, the FDA approved DigniCap for use in breast cancer patients, and this recent approval comes to expand its applicability to other solid tumors where chemotherapies that induce hair loss are used.

The FDA’s decision was supported by results of a clinical study in breast cancer patients (NCT01831024) and by results of studies published in peer-reviewed journals demonstrating the effectivness and safety of the device in patients with tumors in other areas of the body.

The device is not indicated for pediatric patients, patients with cold sensitivity, or other conditions in which cold may cause discomfort or injuries. It also is not approved for use in patients undergoing chemotherapy treatments targeting blood cancers.

The most common side effects associated to the cooling system use are cold-induced headaches, neck and shoulder discomfort, and chills. Pain associated with prolonged use of the cap also was reported. Long-term side effects have not been fully assessed, but the risk of scalp metastasis seems not to differ from that observed in patients who do not use DigniCap.